| CTRI Number |
CTRI/2025/08/092995 [Registered on: 13/08/2025] Trial Registered Prospectively |
| Last Modified On: |
13/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Occupational Therapy ] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Improving Flexibility in Daily Routines: The Impact of Combined Sensory Integration and Behavioral Interventions for Children with Autism Spectrum Disorder |
|
Scientific Title of Study
|
Effectiveness of combined sensory integration and behavioral intervention on insistence of sameness in daily routine among children with Autism Spectrum disorder
Disorder (ASD) |
| Trial Acronym |
SENSE B |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kishor Muthukumar |
| Designation |
PG student |
| Affiliation |
Chettinad Academy of Research and Education |
| Address |
OT-Pediatric Division, Ward No: 24,Department of Occupational Therapy, Chettinad General Hospital,
Chettinad Health City,
Rajiv Gandhi Salai, Kelambakkam.
Rajiv Gandhi Salai
Kelambakkam TN 603103 OT-Pediatric Division, Ward No: 24,Department of Occupational Therapy, Chettinad General Hospital,
Chettinad Health City,
Rajiv Gandhi Salai, Kelambakkam.
Rajiv Gandhi Salai
Kelambakkam TN 603103 Chennai TAMIL NADU 603103 India |
| Phone |
8072285303 |
| Fax |
|
| Email |
kishormot7@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DrBhuvaneshwari S |
| Designation |
Assisstant Professor |
| Affiliation |
Chettinad Academy of Research and Education |
| Address |
OT-Pediatric Division, Ward No: 24,Department of Occupational Therapy, Chettinad General Hospital,
Chettinad Health City,
Rajiv Gandhi Salai, Kelambakkam. OT-Pediatric Division, Ward No: 24,Department of Occupational Therapy, Chettinad General Hospital,
Chettinad Health City,
Rajiv Gandhi Salai, Kelambakkam. Chennai TAMIL NADU 603103 India |
| Phone |
9840016032 |
| Fax |
|
| Email |
bhuvaneshwaris@care.edu.in |
|
Details of Contact Person Public Query
|
| Name |
DrBhuvaneshwari S |
| Designation |
Assisstant Professor |
| Affiliation |
Chettinad Academy of Research and Education |
| Address |
OT-Pediatric Division, Ward No: 24,Department of Occupational Therapy, Chettinad General Hospital,
Chettinad Health City,
Rajiv Gandhi Salai, Kelambakkam. OT-Pediatric Division, Ward No: 24,Department of Occupational Therapy, Chettinad General Hospital,
Chettinad Health City,
Rajiv Gandhi Salai, Kelambakkam. Chennai TAMIL NADU 603103 India |
| Phone |
9840016032 |
| Fax |
|
| Email |
bhuvaneshwaris@care.edu.in |
|
|
Source of Monetary or Material Support
|
| OT-Pediatric Division, Ward No: 24,Department of Occupational Therapy, Chettinad General Hospital,
Chettinad Health City,
Rajiv Gandhi Salai, Kelambakkam. |
|
|
Primary Sponsor
|
| Name |
Kishor Muthukumar |
| Address |
OT-Pediatric Division, Ward No: 24,Department of Occupational Therapy, Chettinad General Hospital,
Chettinad Health City,
Rajiv Gandhi Salai, Kelambakkam.
Rajiv Gandhi Salai
Kelambakkam TN 603103 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kishor Muthukumar |
Chettnad school of Occupational Therapy |
Chettinad Academy of Research and Education
Chettinad Health City
Rajiv Gandhi Salai
Kelambakkam TN 603103 Chennai TAMIL NADU |
8072285303
kishormot7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CARE IHEC-I |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F840||Autistic disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
sensory integration and
behavioral intervention |
Control group participant will receive common occupational intervention Experimental group receive both behavior and sensory intervention.
sensory integration and
behavioral intervention
Duration: 45 minutes per session for 8weeks (3days/weeks).
|
| Comparator Agent |
WeeFIM
|
Effect of intervention will be assessed by comparing the results of the pre test collected in the beginning and post test after completing the of 8 weeks intervention period |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Male |
| Details |
Autism Spectrum Disorder children with both sensory and behavioral issues age group of 7-12 years of age. Diagnosed with Autism Spectrum Disorder (DSM-5 criteria) |
|
| ExclusionCriteria |
| Details |
Children with other behavioural condition like ADHD ,ODD, Conduct disorder and below 7 years of age and teenagers
Significant physical disabilities preventing participation
Severe cognitive impairment IQ less than 50 |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
WeeFIM
Repetitive Behavior Scale-Revised (RBS-R) |
2 months (8 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="2" Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Autism Spectrum Disorder ASD is a complex neuro developmental condition characterized by deficits in social communication and the presence of restricted and repetitive behaviors RRBs including Insistence on Sameness IS a strong preference for routine and resistance to change IS behaviors often interfering with learning adaptability and daily functioning particularly in early childhood when developmental flexibility is crucial While Behavioral Interventions like Functional Communication Training are effective in addressing maladaptive behaviors and Sensory Integration Therapy SIT is commonly used to manage sensory processing difficulties very few studies have evaluated the combined effectiveness of these approaches in reducing IS behaviors specifically related to daily routines Children with ASD often exhibit IS as a coping mechanism for underlying sensory dysregulation Therefore a combined approach targeting both behavioral rigidity and sensory processing dysfunction may be more effective than isolated interventions This dual focus intervention could provide meaningful improvements in behavioral flexibility independence and overall quality of life Given the limited empirical evidence from Indian contexts there is a pressing need for research to validate culturally and contextually relevant interventions that address IS in daily life among Indian children with ASD Insistence on sameness IS is a core feature of autism spectrum disorder ASD characterized by a preference for routines resistance to change and repetitive behaviors These behaviors often manifest in daily routines leading to significant challenges in flexibility and adaptability The repetitive behavior scale revised RBS R is a commonly used tool to assess the severity of IS behaviors in individuals with ASD Kennedy krieger institute Sensory processing dysfunction including hypersensitivity or hyposensitivity to sensory stimuli is prevalent among children with ASD This dysfunction can exacerbate IS behaviors as individuals may seek predictability to manage sensory overload Sensory integration therapy SIT aims to address these sensory processing issues by providing structured sensory experiences to help individuals modulate their sensory responses Behavioral interventions such focus on modifying maladaptive behaviors and promoting functional skills through reinforcement strategies When combined sit and behavioral interventions offer a comprehensive approach to managing IS behaviors by addressing both sensory and behavioral components Previous studies have demonstrated the effectiveness of individual interventions in reducing IS behaviors However there is limited research exploring the combined impact of SIT and behavioral interventions on IS in daily routines among children with ASD This gap underscores the need for empirical studies to evaluate the synergistic effects of these interventions
|